Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT01430858
Eligibility Criteria:
Inclusion Criteria:
* Male or female volunteers, ages 18 to 50 years
* Generally healthy, as determined by review of medical history and physical exam
* Ambulatory
* Willing and physically able to undergo all study procedures
* BMD (measured by DXA) at the lumbar spine and hip within ± 2 SD of the young normal range
* BMI \< 30
Exclusion Criteria:
* Previous diagnosis of osteoporosis
* History of fracture of the spine, pelvis, leg or foot
* History of bone or joint disorders affecting the shoulders, spine, pelvis, legs or feet (e.g. arthritis, congenital hip dislocation, spinal spondylolisthesis)
* Ongoing conditions or diseases known to cause secondary osteoporosis
* Malabsorption syndromes (e.g. coeliac or Crohn's disease)
* Known disorders of calcium metabolism
* Known history of thyroid disease
* Osteomalacia
* Paget's disease
* Diabetes
* History of cancer within the previous 5 years
* Epilepsy
* Ongoing conditions or use of medications that may impair vision or balance
* Use of the following medications within the previous 2 years
* Bisphosphonates
* Fluoride (except use for oral hygiene)
* Strontium
* Teriparatide
* Other bone agents (e.g. SERMs, isoflavones, HRT, calcitonin etc)
* Steroids
* Alcohol abuse or illicit drug use
* Pregnancy or currently trying to conceive (women only)
* Inability to give informed consent
* Known hypersensitivity to the antibiotic penicillin or cephalosporins
* Known hypersensitivity to the local anaesthetic lignocaine.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01430858
Study Brief:
Protocol Section:
NCT01430858